FDA Adverse Event
Injury
Summary report: N
REJUVENATE MODULAR NECK
MDR report key: 2896155
·
Received December 27, 2012
Report
- Report Number
- 9616680-2012-01510
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- August 2, 2010
- Report Date
- December 11, 2012
- Manufacturer
- STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED RECALL LETTER IN AUGUST FROM SURGEON. PATIENT STATES THAT SHE DISLOCATED HER HIP AND HAS A TORN TENDON. PATIENT STATES THAT SHE HAS TO SCHEDULE REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE MODULAR NECK | IMPLANT | JDI | STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI | NA | 25367101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |